ODAN LEVOCARNITINE SOLUTION
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
05-09-2019
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Aktívna zložka:
LEVOCARNITINE
Dostupné z:
ODAN LABORATORIES LTD
ATC kód:
A16AA01
INN (Medzinárodný Name):
LEVOCARNITINE
Dávkovanie:
100MG
Forma lieku:
SOLUTION
Zloženie:
LEVOCARNITINE 100MG
Spôsob podávania:
ORAL
Počet v balení:
15G/50G
Typ predpisu:
Prescription
Terapeutické oblasti:
CALORIC AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0127168003; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2019-09-09
Súhrn charakteristických
PRODUCT MONOGRAPH
Pr
ODAN LEVOCARNITINE
Levocarnitine Oral Solution, USP
100 mg / mL
Amino Acids and Derivatives
Odan Laboratories Ltd.
325 Stillview Avenue
Pointe-Claire, QC
H9R 2Y6
Date of Preparation:
September 5, 2019
Submission Control No:222026
ODAN LEVOCARNITINE Product Monograph
Page 2 of 21
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.....................................................................................
4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
.............................................................11
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..............................................................................................................
16
DETAILED PHARMACOLOGY
..........................................
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